PATIENT ADVICE

- Tell your doctor and/or pharmacist if symptoms continue or worsen after 2 weeks.

- Inform your doctor and/or pharmacist if you experience any of these symptoms:

* Fever, pain or burning when urinating, or blood in the urine.

CONTRAINDICATIONS

- Hypersensitivity to any component of the medication.

Cases of cross-sensitivity have been described between different species of the Asteraceae family, so people allergic to other plants of this family (artichoke, calendula, chamomile) should avoid using milk thistle.

- Liver or biliary diseases, such as [HEPATITIS], [CHOLANGITIS] or [CHOLELITHIASIS].

- Active peptic ulcer.

- [INTESTINAL] or hepatic OBSTRUCTION.

ADVANCED AGE

No specific problems have been described in the elderly that would require a dosage adjustment.

EFFECTS ON DRIVING

It does not appear to have significant effects.

PREGNANCY

Animal safety : no data available.

Safety in humans : There are no adequate and well-controlled studies in humans. Its use during pregnancy is not recommended.

Effects on fertility : no specific studies have been conducted in humans.

INDICATIONS

- Symptomatic treatment of [DYSPEPSIA], such as indigestion, [GASTRIC HYPERACIDITY], [ABDOMINAL DISTENSION], [FLATULENCE] and [NAUSEA].

Its use is based exclusively on traditional use.

INTERACTIONS

They have not been described.

LACTATION

Animal safety : no data available.

Safety in humans : There are no adequate and well-controlled studies in humans. Its use during breastfeeding is not recommended.

CHILDREN

Safety and efficacy have not been evaluated in children and adolescents < 18 years, therefore its use is not recommended.

GUIDELINES FOR PROPER ADMINISTRATION

Swallow the tablets with a sufficient amount of liquid.

Administration with food : can be taken with or without food.

POSOLOGY

- Adults: 1 tablet, twice a day.

- Children and adolescents < 18 years: not recommended.

- Elderly: no specific dosage recommendations have been made.

Missed dose : Take the next dose at the usual time. Do not double the next dose.

DOSAGE IN HEPATIC INSUFFICIENCY

No specific dosage recommendations have been made.

DOSAGE IN RENAL INSUFFICIENCY

No specific dosage recommendations have been made.

PRECAUTIONS

- Patients with [RENAL INSUFFICIENCY], [HEPATIC INSUFFICIENCY], [DIABETES] or a history of [PEPTIC ULCER]. Possible worsening.

ADVERSE REACTIONS

Adverse reactions are described according to each frequency interval, being considered very common (>10%), common (1-10%), uncommon (0.1-1%), rare (0.01-0.1%), very rare (<0.01%) or of unknown frequency (cannot be estimated from the available data).

- Immune system disorders: frequency unknown [HYPERSENSITIVITY REACTIONS], with [URTICARIA], [SKIN RASHES], [PRURITUS].

- Nervous system disorders: frequency unknown [HEADACHE].

- Gastrointestinal disorders: frequency unknown [NAUSEA], gastric discomfort, [DIARRHEA], stomach cramps, [ABDOMINAL PAIN], [GASTRIC HYPERACIDITY].

OVERDOSE

Symptoms : no cases have been described.

Measures to be taken :

- Antidote: there is no specific antidote.

- General elimination measures: none have been established.

- Monitoring: patient's clinical status.

- Treatment: symptomatic.